Certara reported that its drug development software, including modeling and simulation services, supported 95% of the 20 novel drugs approved by the FDA in the first half of this year. The number emphasizes how important in silico tools have become in regulatory submissions, the company said.
The FDA has been steadily working to integrate computer modeling into its review processes as it modernizes its centers, ushered along by legislation such as the 21st Century Cures Act and the latest round of the agency’s user fee reauthorization bills.
“Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs,” FDA Commissioner Scott Gottlieb said last summer in an agency blog post. “This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials.”
The FDA’s Center for Drug Evaluation and Research uses modeling to predict clinical outcomes and safety, inform trial designs and optimize dosing, he added—for example, by applying individual physiology and genetics in drug metabolizing enzymes to identify patient subgroups that need dose adjustments.
The agency also uses simulations to help build natural history databases, with the aim of modeling aspects of trials’ placebo arms, including in Parkinson’s, Huntington’s and Alzheimer’s diseases, as well as muscular dystrophy.
Other applications include using modeling and simulations to predict a drug’s effects in children based on its performance in adults, as described in an agency guidance last December. Using Gaucher disease as an example, the FDA detailed how companies can collaborate on multidrug clinical trials.
In June, Gottlieb and CDER Director Janet Woodcock offered details on the modernization of the FDA’s drug review office, including “the more widespread use of modeling and simulation,” as well as using real-world evidence in pre- and postmarket settings.
“We want to give our clinicians and scientists more time, better tools and greater support to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy,” Gottlieb said, with the goal of providing hundreds of new product-specific and clinical guidance documents and improving efficiency by a minimum of 20%.
Certara, meanwhile, has been expanding its offerings as well, recently acquiring Analytica Laser and its work in real-world effectiveness prediction, value assessments and health economics and outcomes research.
In addition, Certara acquired life sciences data visualization software-as-a-service company BaseCase in February, which helps biopharma and medtech companies visualize model results and real-world datasets as presentations for payers and healthcare providers using an interactive platform.
“Our mission is to revolutionize the drug development paradigm by leveraging modern quantitative approaches such as modeling and simulation and real-world evidence solutions to optimize R&D productivity, commercial value and patient outcomes,” said Certara CEO Edmundo Muniz in a statement. “These technologies’ positive impact is evident in the accelerated development cycles for these approved drugs and the innovation adoption by the FDA.”